VahatiCor Begins United States SERRA-I Early Feasibility Study of A-Flux Reducer System for Microvascular Dysfunction

June 19, 2026—VahatiCor, Inc., a developer of interventional therapies for coronary microvascular dysfunction (CMD), announced the enrollment of the first United States patient in its SERRA-I early feasibility study.

The company stated that A-Flux is a nitinol, self-expanding, repositionable coronary sinus reducer delivered by catheter to the coronary sinus. It is designed to influence blood flow through the heart’s smaller vessels and address the underlying CMD.

This early feasibility study is part of the company’s broader SERRA clinical program that involves centers across the United States and European Union. The study builds on early human experience from SERRA-I and the ongoing enrollment in the SERRA-I European study, noted the company.

According to VahatiCor, SERRA-I is evaluating the initial use of the A-Flux reducer system in patients with symptomatic CMD.

The first patient in the United States study was enrolled Samit Shah, MD, at Yale-New Haven Hospital in New Haven Connecticut. Dr. Shah, who serves as a Coprincipal Investigator of SERRA-I, is an interventional cardiologist with Yale New Haven Hospital Heart & Vascular Center and Assistant Professor of Medicine at Yale School of Medicine.

“Patients with CMD are highly symptomatic and underserved by current therapies, with no approved option in the United States that directly targets microvascular disease,” commented Dr. Shah in the VahatiCor press release. “Enrolling our first United States patient is an important step in generating the evidence these patients need.”

VahatiCor, a T45 Labs portfolio company, advised that the A-Flux reducer system is an investigational device and has not been approved by the FDA for commercial use.